A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
• Adequate bone marrow and other vital organ functions
• Adequate liver function tests
• Metastatic Castration-resistant Prostate Cancer
Locations
Other Locations
Australia
Cancer Research SA
RECRUITING
Adelaide
Southern Oncology Clinical Research Unit
RECRUITING
Adelaide
Icon Cancer Centre South Brisbane
RECRUITING
Brisbane
John Flynn Private Hospital
RECRUITING
Brisbane
Eastern Health (Box Hill Hospital)
RECRUITING
Melbourne
Linear Clinical Research Ltd
RECRUITING
Perth
GenesisCare North Shore (Oncology)
RECRUITING
Sydney
Macquarie University
RECRUITING
Sydney
MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy
RECRUITING
Sydney
Sydney Adventist Hospital
RECRUITING
Sydney
Illawarra Shoalhaven Local Health District (Wollongong Hospital)
RECRUITING
Wollongong
Contact Information
Primary
Kathy You
kathyyou@atridia.com
+61 02 9299 0433
Backup
Ravi Patel
ravi.patel@atridia.com
+61 452 363 506
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 25
Treatments
Experimental: : HRS-5041 dose level 1
240 mg BID
Related Therapeutic Areas
Sponsors
Leads: Atridia Pty Ltd.